Non-Standard Modes of Transportation for Cell & Gene Therapies | Executive Insights with Carson Dickey
Recently, while attending the Allogenic Cell Therapy Summit in Boston, MA, Carson was at...
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How do you go about integrating your cold chain and what is involved? To fully integrate your cold chain there are three (3) departments that need to be working together:
Start with the end in mind. Transport validation. Answer the question “What will it take to validate transport”? Look at transport validation just like you would validating a filling line. Treat transportation as an extension of manufacturing. Once you know what the end should look like the key is to not get overwhelmed and try to do everything at once.
Start easy; develop a smart, platforms based packaging qualification program that includes primary, secondary, devices, and cold chain shippers. From there move on to supporting your packaging qualification program by integrating your transport and distribution processes. Develop systems and processes, which provide control over the process and feedback/metrics of your transport environment, “close the loop”.
Finally take on the toughest of them all. Integrate product development into the entire process. While this may be the toughest it will have largest positive impact on your company’s operations. Integrating your product development into your cold chain or controlled environment logistics network will do many things such as:
Recently, while attending the Allogenic Cell Therapy Summit in Boston, MA, Carson was at...
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